New Delhi: The Pune-based Serum Institute of India (SII) — one of the world’s largest manufacturers of vaccines — has reached out to the Drug Controller General of India (DCGI), highlighting the difficulties it is facing in continuing clinical trials of non-Covid-19 vaccines, ThePrint has learnt.
The company, which produces 1.5 billion doses of vaccines annually, has highlighted difficulties in continuing clinical trials for at least three of its non-Covid vaccines due to the pandemic.
The company has told the DCGI, the apex body that approves vaccines and their clinical trials in India, about difficulties in conducting trials on Tdap (Tetanus, Diphtheria and Pertussis) vaccine, Hexavalent vaccine and Quadrivalent Human Papillomavirus Vaccine (HPV). Hexavalent vaccine, as the name suggests, gives immunity against six diseases, whereas HPV protects against various cancers, including cervical cancer.
“The firm presented the difficulties in continuing the clinical trial due to the prevailing Covid-19 pandemic and also presented proposed amendment in Phase II/III clinical trial… in already enrolled subjects,” according to the minutes of the meeting of the Subject Expert Committee (SEC), accessed by ThePrint. The SEC has been appointed by the DCGI to review proposals related to clinical trials and advise the regulator on them.
The meeting was held on 6 July and the DCGI has granted the “proposed amendments”.
The SII is among the top companies in the world working on three vaccine candidates for Covid-19. It is working on vaccine candidates developed by the University of Oxford, US-based Codagenix and Austrian biotech firm, Themis.
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What are the difficulties?
Adar Poonawalla, chief executive officer of the SII, told ThePrint: “Due to Covid-19 pandemic, the hospital authorities have restricted clinical trial activities affecting new enrollment of subjects in clinical trials.”
“Also, some of the hospitals have started Covid wards or have become Covid hospitals, thus affecting the enrollment of subjects in the ongoing clinical trials,” he added.
Poonawalla, who is also the president of Indian Vaccine Manufacturers’ Association, said: “Due to Covid-19 pandemic, parents or subjects are scared to come for further follow-up visits.”
He added, “The subsequent dosing of the enrolled subjects has been delayed, thus having an impact on the vaccination schedule given in the protocol. Moreover, follow-up visits for vaccination, safety assessment as well as blood withdrawal are delayed.”
What can be done to avoid delay?
Poonawalla said that “fear psychosis about visiting hospitals should be removed” to avoid delay in trials of non-Covid vaccines.
“People should be encouraged to take part in trials. Hospital authorities should be encouraged to continue routine clinical trials and give adequate support for them. Regulators should adopt a flexible approach,” he said.
Poonawalla also said it’s not only the SII, but “all companies (vaccine makers) must be facing the same issues, not just in India but everywhere in the world”.
What has the government suggested?
Poonawalla told ThePrint the government is “fully cognisant about the ground reality and have been very supportive”.
The DCGI committee has reviewed the company’s challenges and granted the “extension of window period for follow-up visits”, among other changes requested in the designed protocol, he said.
According to the minutes of the meeting, “after detailed deliberation, the committee recommended for grant of approval for proposed amendments with respect to the subjects already enrolled in the study”.
It has also advised the company that “further subject recruitment should be carried out after assessing the feasibility of conducting and continuing the study due to the prevailing Covid situation”.
It also said: “The statistical evaluation of the subjects who are continuing in the study after the delayed vaccination should be presented separately.”
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